Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation
本文指出当前医疗设备监管框架过时，不适合含软件的新一代设备，并提出基于两阶段审查的自愿替代路径，以应对市场变化。
Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.